Stroke
Conditions
Keywords
stroke, rehabilitation, Task-oriented training (TOT), virtual reality (VR), upper limb dysfunction
Brief summary
Stroke rank second among the top causes of death, affecting millions of people in the worldwide. It has been reported that hemiplegia is the most common sequelae after stroke, accounting for about 50%-70% of all sequelae of the disease. About 75% of stroke patients are accompanied by different degrees of upper limb dysfunction, which seriously affects the activities of daily life and cause serious physical and mental burden to patients and their families. Early recovery of upper limb motor function is a great significance for the overall recovery of stroke patients. Task-oriented training (TOT) is reported to improve the motor coordination and ADL. However, lack varies of tasks limited the treatment ability for patients with stroke hemiplegia during hospital admission. Virtual reality (VR) offers advantages of providing virtual scenes that is difficult in the real world, such as the scene of garden, camara, and plaza etc. And the familiar circumstances for patients may have the potential to increase the motivation of rehabilitation training, and improve the efficacy of occupational therapy (OT). The goal of this study is to observe the effectiveness of real home settings via virtual reality assisted TOT on upper limb function in patients with stroke. Functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG) were used to observe the changes in brain function under VR-TOT training. We intended to recruit 120 participants, and allocate to three groups: VR-TOT, TOT, and traditional OT. Each of them completed the Fugl-Meyer-UE, Wolf motor function test (WMFT), hand gripping power, modified Ashworth、Purdue Pegboard test （PPT）、modified Barthel index (MBI)、mini mental state examination (MMSE)、NIH stroke scale (NIHSS)、Virtual reality sickness questionnaire (VRSQ), Intrinsic Motivation Inventory Inventory (IMI), satisfaction VAS, body representation, sense of ownership, Proprioceptive Drift scale before and after the treatment. Additionally, we conducted fNIRS and EEG at baseline and during the follow up to understand the changes in brain function.
Interventions
The participants' in this group were given VR-TOT training under real home scenes created in the platform of Unity. There were 6 VR-TOT tasks, and the task choice was according to the performance of participants' upper limb function. The experienced therapist will guide and monitor the participants and adjust the task if necessary.
Sponsors
Qilu Hospital of Shandong University
First Affiliated Hospital of Chongqing Medical University
Shanghai Sunshine Rehabilitation Center
Beihang University
Huashan Hospital
Jinan Hospital
Jinan Seventh People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-1. Ischemic or hemorrhagic stroke was diagnosed based on the history, symptoms, and signs combined with CT or MRI imaging; 2. First stroke, onset time from 1 to 6 months, age ≥ 18 - 80 years ; 3. Hemiplegia, Brunnstrom stage ≥ Ⅱ - Ⅴ, modified Ashworth grade \< 4; 4. Able to maintain sitting balance (with no or only minimal assistance) for at least 30 minutes to facilitate assessment and training; 5. No significant unilateral neglect (confirmed by tests such as the Schenkenberg Line Bisection Test); visual or corrected vision and hearing must be sufficient to meet the requirements for VR training and to understand instructions. 6.Patients or their family members signed informed consent to participate in the experiment.
Exclusion criteria
* 1\. Previous history of stroke, traumatic or non-vascular encephalopathy; 2. MOCA ≤ 17, and no sensory aphasia. 3. Skull defect or allogeneic repair; 4. combined with other neurological and mental diseases; 5. Previous diseases that may cause upper limb motor/sensory dysfunction, such as neck tumor or radiotherapy and chemotherapy history, cervical spondylosis, cervical spine or upper limb fracture history, traumatic brachial plexus injury history, arthritis, diabetes mellitus, myasthenia gravis, multiple sclerosis, etc. 6\. Accompanied by obvious vertigo or dizziness symptoms or related diseases (such as motion sickness, Meniere's syndrome, otolithiasis, etc.); 6. Accompanied by obvious pain; 7. Significant pain in the affected upper limb or shoulder at rest or during activity (VAS ≥ 4 ) 8. Evidence of ataxia and cerebellar or brainstem lesions according to the NIHSS; 9. Ongoing participation in other clinical investigators; 10. Unstable condition, refusal to sign the informed consent, and unwillingness to cooperate with the examination and treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE) | There were 4 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks，1 month after the intervention |
Secondary
| Measure | Time frame |
|---|---|
| The grip strength of the hand | There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks |
| the Modified Ashworth scale | There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks |
| Montreal Cognitive Assessment(MoCA) | There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks |
| Box and Block Test（BBT） | There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks |
| Modified Barthel Index Scale(MBI) | There were 4 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks, 1 month after the intervention |
| Intrinsci Motivation Inventory (IMI) | There were 3 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 2 weeks, the intervention of 4 weeks |
| Visual Analogue Scale（VAS） | There were 4 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks，1 month after the intervention |
| the sense of ownership (SOO) | There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks |
| the questionnaire and self-location drift | There were 3 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 2 weeks, the intervention of 4 weeks |
| fNIRS | There were 2 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 4 weeks |
| EEG | There were 2 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 4 weeks |
| Catherine Bergego Scale（CBS） | There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks |
| line bisection test | There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks |
Countries
China
Contacts
CONTACTjing Jing
Outcome results
None listed